Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component for the MAGNUS operating table sys
FDA device recall Z-0480-2010 · posted 2009-12-02 · Terminated
Recall details
- Recalling firm
- Maquet Inc.
- Reason for recall
- Product monitoring has determined that the connection bracket shows potential mechanical play at the OR table interface for some procedures. This is due to the hole in the lock washer, which is responsible for locking the accessory to the OR table, being too large.
- Action taken
- Urgent Device Correction Letters were sent by Federal Express to affected US hospitals on October 22, 2009. The letter stated the technical description, potential hazard, and the recommended precaution. The letter asked customers to immediately verify whether their Connection Bracket is affected thru the FaxBack provided. Questions or need for additional information can be directed to customers' local MAQUET representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FWZ
- Quantity affected
- 9 units in US.
- Distribution
- Nationwide Distribution -- USA, including states of SC and PA.
- Date initiated
- 2009-10-22
- Date posted
- 2009-12-02
- Date terminated
- 2010-05-18
- Location
- Wayne, NJ
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